The purpose of this study is to compare the rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 3 weeks of follow-up.

LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix

Other Name: LEEP

Detailed Description:

The recent scale-up of antiretroviral treatment programs in resource-limited settings provides an unprecedented opportunity to implement a comprehensive cervical cancer screening and treatment program for women who, by virtue of having HIV, are at significant risk for cervical disease. Unfortunately, even if screening is offered free of charge to millions of women living with HIV, it is unclear which treatment modality for pre-cancerous cervical lesions will be most effective since HIV appears to affect outcomes of treatment by increasing the recurrence and severity of cervical disease. Cervical treatment may also increase shedding of HIV from the cervix which may put discordant couples at risk and possibly spread HIV more widely. This study proposes to randomize HIV-positive women with cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) to cryotherapy vs. loop electrosurgical excision procedure (LEEP) and measure the recurrence of cervical disease in each group over 2-years of follow-up as well as HIV shedding from the cervix for 6 weeks after treatment.

Our hypothesis is that compared to cryotherapy, LEEP is significantly more likely to prevent recurrence of cervical lesions over 2 years of follow-up and less likely to cause shedding of HIV-1 from the cervix over 3 weeks of follow-up.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV positive receiving care at the Coptic Hope Center

Not pregnant by clinical examination or history

Have an intact cervix

Have not received prior cervical treatment

Do not have a history of a bleeding disorder

Are above 18 years of age

Exclusion Criteria:

HIV-negative

Male

Below 18 years of age

Pregnant by clinical examination or history

Post-hysterectomy

Post-cervical cancer treatment.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298596